Difference between revisions of "Pegaspargase (Oncaspar)"
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==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2016-01-14: Initial authorization | *2016-01-14: Initial authorization | ||
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| + | ==History of changes in PMDA indication== | ||
| + | *2023-06-26: A drug with a new active ingredient indicated for the treatment of [[:Category:Acute lymphoblastic leukemias|acute lymphocytic leukemia]]. | ||
| + | *2023-06-26: A drug with a new active ingredient indicated for the treatment of [[:Category:Lymphomas|malignant lymphoma]]. | ||
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==Also known as== | ==Also known as== | ||
*'''Generic names:''' PEG-L-asparaginase, peg-asparginase, pegasparaginase | *'''Generic names:''' PEG-L-asparaginase, peg-asparginase, pegasparaginase | ||
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[[Category:FDA approved in 1994]] | [[Category:FDA approved in 1994]] | ||
[[Category:EMA approved in 2016]] | [[Category:EMA approved in 2016]] | ||
| + | [[Category:PMDA approved in 2023]] | ||
[[Category:WHO Essential Cancer Medicine]] | [[Category:WHO Essential Cancer Medicine]] | ||
Latest revision as of 03:48, 1 June 2024
General information
Class/mechanism: Depletes plasma asparagine, selectively killing leukemic cells which are unable to synthesize asparagine due to a lack of asparagine synthetase. The Oncaspar formulation involves L-asparaginase (L-asparagine amidohydrolase) being covalently conjugated to monomethoxypolyethylene glycol (mPEG), increasing its half-life and reducing the risk of hypersensitivity reactions in patients who have history of hypersensitivity to Asparaginase (Elspar).[1][2]
Route: IV, IM
Extravasation: neutral
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
- B-cell acute lymphoblastic leukemia
- Extranodal NK- and T-cell lymphoma, nasal type
- NK- and T-cell lymphoma
- T-cell acute lymphoblastic leukemia
Patient drug information
- Pegaspargase (Oncaspar) patient drug information (Chemocare)[3]
- Pegaspargase (Oncaspar) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 1994-02-01: Initial FDA approval for treatment of acute lymphocytic leukemia (ALL) in patients who require L-asparaginase in their treatment regimen but have developed hypersensitivity to the native forms of L-asparaginase. (Based on CCG 1962)
- 2006-07-24: FDA approved for the first-line treatment of patients with acute lymphoblastic leukemia. (Based on CCG 1962)
History of changes in EMA indication
- 2016-01-14: Initial authorization
History of changes in PMDA indication
- 2023-06-26: A drug with a new active ingredient indicated for the treatment of acute lymphocytic leukemia.
- 2023-06-26: A drug with a new active ingredient indicated for the treatment of malignant lymphoma.
Also known as
- Generic names: PEG-L-asparaginase, peg-asparginase, pegasparaginase
- Brand name: Oncaspar
References
- Drugs
- Pegylated medications
- Intramuscular medications
- Intravenous medications
- Neutral
- Asparagine-specific enzymes
- B-cell acute lymphoblastic leukemia medications
- Extranodal NK- and T-cell lymphoma, nasal type medications
- NK- and T-cell lymphoma medications
- T-cell acute lymphoblastic leukemia medications
- FDA approved in 1994
- EMA approved in 2016
- PMDA approved in 2023
- WHO Essential Cancer Medicine